Body Composition Reference Data for Preterm Infants

Completed

• Conditions: Preterm Birth

• Registration Number: NCT02855814
• Lead Sponsor: University of Minnesota

Brief Summary

The American Academy of Pediatrics has recommended that growth in size (weight, length, and head circumference) and in body composition (fat and lean mass) in preterm infants should adhere as close as possible to the growth and body composition of a healthy infant in utero at the same gestational age. However, there are no body composition reference curves available at this time for the preterm infant population. The purpose of this study is to collect cross-sectional body composition data using air displacement plethysmography (PEA POD Infant Body Composition System, Life Measurement, Inc) on approximately 240 preterm infants within 3 days of birth, for the purpose of generating means, standard deviations, and percentile values for total body fat mass, total fat free mass, and percent body fat for infants born at 30-36 weeks gestation. Relatively healthy infants without evidence of growth retardation will be selected for form the reference sample. The goal is to generate a set of common reference curves to be used in clinical centers against which to compare body composition status for individual infants.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2016-07-27
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

Inclusion Criteria

• Appropriate for gestational age (AGA), singleton, 30+0 and 36+6 weeks gestational age

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Exclusion Criteria

• Congenital defects that affect growth
• Inability to tolerate room air for 5 minutes without desaturation or bradycardia
• <1 kg birth weight
• Parents did not provide consent

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fat mass	Within 72 hours of birth	Total body fat mass measured by air displacement plethysmography, in kg
Fat-free mass	Within 72 hours of birth	Total body fat-free mass measured by air displacement plethysmography, in kg
Percent body fat	Within 72 hours of birth	Percent body fat measured by air displacement plethysmography, in %